Status:
UNKNOWN
Evaluation of the Application of PEGylated Recombinant Human Granulocyte Stimulating Factor Injection (PEG-rhG-CSF) in Chemotherapy of Elderly Lymphoma Patients
Lead Sponsor:
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Conditions:
Elderly Lymphoma Patients
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
A multicenter, open, one-arm clinical study evaluated the efficacy and safety of Jinyouli in preventing neutropenia after chemotherapy in elderly lymphoma patients who met the criteria for admission. ...
Eligibility Criteria
Inclusion
- (1) Age ≥ 65 years, gender is not limited;
- (2) Patients with lymphoma diagnosed by histopathology or cytology;
- (3) Patients requiring multi-cycle chemotherapy;
- (4) Planned chemotherapy regimen FN risk ≥ 20 % (see Annex I), or 10% \<FN risk \< 20% (see Annex II) with high risk factors for at least one FN;
- (5) Physical status (KPS) score ≥ 70 points;
- (6) Expected Survival period of more than 3 months;
- (7) normal bone marrow hematopoietic function (ANC ≥1.5×109/L, PLT≥100×109/L, Hb≥80g/L, WBC≥3.0×109/L);
- (8) The testers (or their legal representatives/guardians) must sign an informed consent form.
Exclusion
- (1) Lymphoma central involvement;
- (2) Hematopoietic stem cell transplantation or organ transplantation;
- (3) Insufficient local or systemic infection;
- (4) Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
- (5) Liver function tests total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are \>2.5 times the upper limit of normal, if the above indicators are \>5 times due to liver metastasis Upper limit of normal value; renal function test: serum creatinine (Cr) \> 2 times the upper limit of normal;
- (6) allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
- (7) Severe mental illness, affecting informed consent and/or adverse reaction expression or observation;
- (8) The investigator judges patients who are not suitable for participation.
Key Trial Info
Start Date :
February 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 22 2021
Estimated Enrollment :
485 Patients enrolled
Trial Details
Trial ID
NCT03870412
Start Date
February 22 2019
End Date
August 22 2021
Last Update
March 14 2019
Active Locations (1)
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1
Sun Yat-sen University Cancer Hospital
Guangzhou, China